MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX448L60MG
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that the tubing of a medex¿ magnum¿ micro fluid delivery system became disconnected from the patient's peripherally inserted central catheter line (picc).The disconnection occurred where the 3 way stopcock connects.The picc line was placed in the patient's left forearm, and the iv lumen device type was single.The tubing had been hanging for 72 hours without any disconnections, the disconnection only occurred when transferring the infant to be held by its mother.New tubing was hung and total parenteral nutrition was reconnected to the patient.No injury was reported.

• Brand Name: MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6711914
• Report Number: 3012307300-2017-01479
• Device Sequence Number: 210563
• Product Code: FPA
• UDI-Device Identifier: 10351688507372
• UDI-Public: 10351688507372
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: MX448L60MG
• Device Lot Number: 3363821
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1